A Multicenter, Open-Label, Randomized, Phase III Trial Comparing Immediate Adjuvant Hormonal Therapy (ELIGARD®- Leuprolide Acetate) in Combination With TAXOTERE® (Docetaxel) Administered Every Three Weeks Versus Hormonal Therapy Alone Versus Deferred Therapy Followed by the Same Therapeutic Options in Patients With Prostate Cancer at High Risk of Relapse After Radical Prostatectomy

Trial Information

A Multicenter, Open-Label, Randomized, Phase III Trial Comparing Immediate Adjuvant Hormonal Therapy (ELIGARD®- Leuprolide Acetate) in Combination With TAXOTERE® (Docetaxel) Administered Every Three Weeks Versus Hormonal Therapy Alone Versus Deferred Therapy Followed by the Same Therapeutic Options in Patients With Prostate Cancer at High Risk of Relapse After Radical Prostatectomy

The study consisted of the following:

- Randomization of eligible participants within 120 days of prostatectomy

- For participants assigned to immediate therapy, a treatment period up to 18 months within 8 days of randomization

- For participants assigned to deferred treatment, a treatment period up to 18 months after evidence of progression prior to December 2010. Participants who did not progress before December 2010 were withdrawn from the study.

Inclusion Criteria:

Participants who met all of the following criteria were considered for enrollment into the study.

- Pathologically confirmed adenocarcinoma of the prostate based on central pathology review. All other variants are excluded

- Randomization should occur less than 120 days after prostatectomy AND lymphadenectomy.

- A predicted probability of 5-year freedom from progression ≤ 60%, as determined by the postoperative nomogram developed by M. Kattan.

- Total serum bilirubin ≤ UNL for the institution. Participants with Gilbert's syndrome may be eligible if indirect serum bilirubin levels at the time of randomization and, at least 6 month prior to randomization, confirm this condition (i.e. elevated indirect serum bilirubin).

- Post operative PSA necessary for eligibility is defined as a level ≤ 0.2ng/mL using a standard assay at least 30 days after radical prostatectomy and within 7 days prior to randomization. Note that randomization should occur within 120 days after radical prostatectomy

Participants presenting with any of the following will not be included in the study.

- Prior systemic treatment for prostate cancer with hormonal therapy, chemotherapy, or any other anticancer therapy.

- Prior radiation therapy.

- Participants who received, are receiving or scheduled to receive post-operative radiotherapy.

- Participants taking alternative therapies for cancer must stop taking these therapies prior to randomization. Alternative therapies are not allowed during the treatment or follow-up portions of the study. This includes (but is not limited to) alternative therapies such as :

- PC-SPES (all types)

- 5-alpha reductase inhibitors

- Bisphosphonates are to be stopped prior to randomization and are not allowed during the study.

- History of a malignancy other than prostate cancer. Exceptions to these criteria include:

- participants with adequately treated non-melanoma skin cancers, and

- participants with a history of another malignancy that was curatively treated (including participants with superficial bladder cancer) and who have not had evidence of disease for a minimum of 5 years.

- Peripheral neuropathy ≥ Grade 2.

- Electrocardiogram (ECG) with significant abnormalities (as determined by the investigator) within 90 days prior to randomization.

Outcome Measure:

Outcome Description:

PFS is the interval from the date of surgery to date of progression. The date of progression was the earlier of
first PSA increase to ≥ 0.4 ng/mL confirmed within two weeks
date of the nadir, if PSA nadir did not reach < 0.4 ng/mL (for deferred arm)
first radiological/ histological evidence of tumor progression
death. Median PFS was to be estimated using Kaplan-Meier curves. However, enrollment was not met, and meaningful conclusions for efficacy or QoL could not be drawn. Median PFS could not be estimated. Reported is the number of participants with disease progression.

Outcome Time Frame:

from the date of surgery up to 3 years after randomization of the last participant

Completion Date:

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